ClinicalTrials.gg
RecruitingNCT07732023Updated Sep 10, 2026

A Randomized, Phase Ib, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SKB575 (HBM7575) in Participants With Asthma

A Phase 1 interventional study of SKB575 and Placebo in Asthma (Diagnosis), sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (part of Sichuan Kelun Pharmaceutical Co.,Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.

02

Conditions studied

  • Asthma (Diagnosis)

Browse trials for

03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's planned enrollment of 36 is below the median of 78 across 3,341 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is the lead sponsor of 55 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The participant is able to understand and comply with the requirements of this study, and voluntarily signs the form.
  2. Aged between 18 and 70 years inclusive at the time of signing the informed consent form, with no restriction on gender.
  3. (BMI) shall be ≥ 18.0 kg/m² and ≤ 32.0 kg/m².
  4. Diagnosis of asthma consistent with the Global Initiative for Asthma (GINA) 2025 diagnostic criteria.
  5. Pulmonary function test during the screening period must meet either of the following criteria: After albuterol inhalation, the (FEV₁) increases by ≥ 12% with an absolute FEV₁ increment of ≥ 200 mL; or the participant has a positive result from a bronchodilator reversibility test or bronchial provocation test within the past 12 months.
  6. Participants must have received a stable dose of controller medication for a minimum of 3 months prior to randomization. Subjects shall be on maintenance therapy with low-, medium- or high-dose inhaled (ICS), which may be combined with other asthma controller medications including long-acting beta₂ agonists (LABA), long-acting muscarinic antagonists (LAMA), and leukotriene receptor antagonists (LTRA). The treatment regimen and dosage shall remain unchanged throughout the study period.
  7. Pre-bronchodilator forced expiratory volume in one second (FEV₁) ≥ 50% of predicted value during screening.
  8. Male and female participants must agree to use highly effective methods for the specified duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Within 3 months prior to randomization, the participant experienced an acute asthma exacerbation requiring continuous systemic therapy for ≥3 consecutive days, or presented to the emergency department or was hospitalized due to asthma with administration of systemic corticosteroids (calculated from the completion date of treatment for the asthma exacerbation).
  2. Known to the product or its , or a history of allergic reactions to any biological products.
  3. Concomitant pulmonary diseases, including but not limited to pulmonary infection, (COPD), bronchiectasis, interstitial lung disease, pulmonary vascular disease, pulmonary neoplasm, or any other diseases affecting pulmonary function other than asthma.
  4. Concomitant diseases that may impair pulmonary function, including but not limited to clinically significant pleural disorders, mediastinal diseases, diaphragmatic lesions, myasthenia, thoracic deformities, etc.
  5. Concomitant diseases such as rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, primary biliary cholangitis, etc.
  6. Known or suspected history of , including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis and aspergillosis), even if the infection has resolved.
  7. Confirmed parasitic infection within 6 months prior to randomization; upper or lower respiratory tract infection occurring within 6 weeks prior to randomization; other active infections requiring systemic treatment identified within 1 month prior to randomization.
  8. Previous history of malignant neoplasm, regardless of whether treatment was administered, or whether there is evidence of local recurrence or .
  9. Presence of any history of severe clinically significant diseases involving cardiovascular and cerebrovascular systems, hematological system, liver, kidney, digestive tract, nervous system, respiratory system, psychiatric disorders, metabolic abnormalities, or any other diseases or physiological conditions that may interfere with the trial results.
  10. Participants who have undergone or are planning to undergo major surgery within 3 months prior to randomization.
  11. Current smoker at screening, or having quit tobacco (including e-cigarettes) for less than 6 months.
  12. History of drug or alcohol abuse within 2 years prior to randomization.
  13. Female participants who are pregnant or breastfeeding.
  14. Any condition deemed by the investigator to interfere with the evaluation of the investigational product, compromise participant safety, or confound the interpretation of study results.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    SKB575

    Drug: SKB575

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSKB575

    Subcutaneous

  • DrugPlacebo

    Subcutaneous

06

What researchers measure

Primary outcomes

  1. Incidence of participants with adverse events (AEs), serious adverse events (SAE)

    Time frame: From baseline to week 32

  2. Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at week 8

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in FeNO

    Time frame: From baseline to week 32

  2. Change from baseline in pre-bronchodilator (BD) FEV1

    Time frame: From baseline to week 32

  3. Change from baseline in post-BD FEV1

    Time frame: From baseline to week 32

  4. Change from baseline in ACQ-5 score

    ACQ-5 is Asthma control questionnaire assessing symptoms, has a scoring range of 0 to 6 points. Lower score shows better asthma control.

    Time frame: From baseline to week 32

  5. Pharmacodynamic(PD): Changes from baseline in blood eosinophil count (EOS), etc.

    Time frame: From baseline to week 32

  6. Pharmacokinetics (PK): Serum concentration of SKB575

    Time frame: From baseline to week 32

  7. Anti-drug antibodies (ADA) against SKB575

    Time frame: From baseline to week 32

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.

Of 173 industry-sponsored phase 1 interventional studies under Asthma, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's planned 23 months is above that.

Counting every sponsor, half of 200 studies reached it within 6 months; a quarter within 3 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2026
First posted
Jul 28, 2026
StartActual
Aug 25, 2026
Primary completionEst.
Jul 30, 2028
CompletionEst.
Jul 30, 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07732023
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Aug 25, 2026
Primary completion
Jul 30, 2028 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Xin Li, PhD
Contact
lixin@kelun.com
86-028-67255165

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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